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After identifying the need to conduct a human cadaver study for medical device testing or physician bioskills training (review our recent blog post detailing when human cadaver labs provide value over animal studies), the next step is vetting possible locations and ideal partners for your project. This decision should not be taken lightly as the benefits or …

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In the United States more than 2.5 M patients are reported to have significant mitral valve disease with less than 3% of those cases currently being treated.(1) Mitral regurgitation (MR) in Western countries is one of the most prevalent valvular diseases, expecting to affect 5 million US patients in 2030.(1,2) After witnessing the recent success of transcath…

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Studies involving human cadaver tissues can be a valuable resource for companies developing new medical devices. Human cadaver labs allow an entrepreneur to gather integral information about a medical device or procedure including:  Dimensional compatibility of a device with the human anatomy; Spatial interactions between adjacent anatomical structures a…

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Wound healing is a fundamental process to every living organism. Humans have been tending to each others wounds since the day of our creation. The complexity of human wound care has evolved through history from homemade magical potions, incantations, charms, and ointments to institutionally trained physicians, surgeons, and nurses and an ever increasing indu…

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Without a doubt, the enormous expansion of the medical device industry over the past several decades has transformed the practice of healthcare worldwide. Arguably, as Dr. Susan Alpert attested in her April 15th, 2015 keynote at the University of Minnesota’s Design of Medical Devices (DMD) Conference, the medical device industry has had a greater impact on g…

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Aortic stenosis is the most common valvular heart disease in the elderly population, with an incidence of 4.6% in adults over 75 years of age (1). Surgical replacement of a diseased aortic valve is the recommended treatment for a symptomatic patient experiencing congestive heart failure, syncope, or chest pain (2). Many symptomatic patients also experience s…

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Many companies setting out to perform Good Laboratory Practice (GLP) studies want to proceed directly into their GLP preclinical study without conducting a preclinical pilot study first. While, this may make sense in some situations, many times it can introduce more challenges that can be mitigated if a small efficient preclinical pilot study is conducted fi…

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With the beginning of the new year, the CDRH division of the FDA published their lists of proposed Guidance Documents for development and retrospective review in fiscal year 2015. Many of these are relevant to our clients and their preclinical research activities. Each year, CDRH publishes their list as was agreed during the negotiations around the Medical D…

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Despite the relatively recent multi-center clinical trial results, there remains heavy interest and positive momentum in renal denervation (RDN) for the treatment of drug resistant hypertension. With the help from partners such as Alizée Pathology and BASi®, Surpass has compiled key study design considerations for the Test Article, In Vivo Study Design, Anal…

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With the recent approval of the first drug coated balloon (DCB) in the US, and accepted use worldwide, more and more medical device companies are developing drug coated balloons. With the help from partners such as Alizée Pathology and BASi®, below are some key considerations around the Test Article, In Vivo Study Design, Analytical Testing and Histopatholog…

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